Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Bioscience R&D
At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
Come be a part of our team and our mission as a Scientist I in Template Control!
The Scientist I in Template Control (TC) will work on the TC Process Development team to innovate and optimize manufacturing systems. Collaborates with the TC Production and TC Projects teams in assessing current manufacturing processes to identify improvements, then initiates, directs, and executes process research and method development of new or amended processes or process controls for product manufacture to continue to increase product quality and consistency. Principle responsibilities include devising/refining existing processes, planning/executing process research trials, creating/optimizing test methods, developing/supervising validation plans and protocols, creating/updating specifications, analyzing/documenting data in technical reports and records, presenting research/proposals, and others as directed. Works with the TC Projects and TC Production teams in implementation of the above into TC manufacturing systems. Commitment to BioFire Diagnostics’ corporate culture is essential for success as part of the Template Control Process Development team.
Essential Job Duties and Responsibilities
1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Collaborate with TC team members at all levels to identify improvement areas, including new processes, process instrumentation, process controls, test methods, materials, process intermediates, specifications, and other solutions.
3. Plan and execute research and development of new methods and technologies to advance manufacturing as assigned.
4. Coordinate with the TC Production team for personnel, instrumentation, materials, and other lab resources needed in executing research experiments, investigations, studies, validations, and other process development work.
5. Make detailed observations, analyze data, interpret results, and effectively communicate these with colleagues.
6. Review research and development progress with the AD and identify process improvements ready for proposal.
7. Write and submit project proposals to implement process improvements to Program Management and the TC Work Center (WC) team.
8. Assist the TC WC team in evaluating project proposals, and contribute to implementation projects executed by the TC Projects team as a stakeholder, SME, or other functionary.
9. Maintain broad knowledge of state-of-the-art principles and theories.
10. Use professional concepts and strategies in pursuit of company objectives to solve complex problems by creative, effective, and efficient means.
11. Demonstrate drive for technical proficiency, scientific creativity, collaboration with others, and independent thought.
12. Perform other duties as assigned.
Training and Education
Requires a PhD in scientific discipline or equivalent. May also include exceptional non-PhDs with demonstrated capabilities and an equivalent combination of directly related education or experience.
Requires 2 years of experience in a research and/or development environment.
Familiarity with PCR and its variants desired.
Experience working in commercial/industrial microbiology a plus.
Experience in the medical device industry and knowledge of cGMP/QSR/ISO desired.
Knowledge, Skills and Abilities
Apply the scientific method to problem solving, process research, and method development in creative and innovative ways.
Demonstrate literacy in conventional statistical approaches to data analysis, significance, and visualization.
Accurately define problems, devise experiments and experimental methods, analyze data, establish relationships, and draw valid conclusions.
Apply validation strategies to instruments, analytical methods, and processes in accordance with medical device manufacturing industry standards.
Write detailed reports and succinct manufacturing procedures.
Work well independently as well as in team environments.
Structure time effectively, maintain exceptional organization, and efficiently manage multiple projects simultaneously.
Develop, coordinate, and implement multi-level individual and team-based skills.
Utilize well-developed interpersonal communication skills, emotional intelligence, and the ability to relate with personnel at all organizational levels.
Exemplify BioFire Diagnostics’ corporate culture of purpose, opportunity, success, appreciation, well-being, and leadership.
Physical requirements typically found in a lab and office setting.